Pharmaceutical Impurities

Impurities can significantly impact the efficacy and safety of drug products. Accurate detection and control of impurities in drug substances and drug products is an important element of Quality by Design, ICH and GMP requirements. During manufacture of a drug material impurities can arise from many different sources including drug substance residual impurities, degradation, extractables and leachables, as well as impurities present in or derived from excipients. Typically, Pharmacopoeial Monographs identify multiple impurities for a given drug substance that require each impurity to be analytically verified by a chromatographic method. Multiple sample preparations are usually required, the process can be a time consuming burden and offer significant opportunity for increased uncertainty and error in the analysis. With our pharmaceutical impurity solution mixes we do offer a time efficient, accurate and reproducible way for pharmaceutical analysis.